Summary: In children and adolescents with youth-onset type 2 diabetes inadequately controlled on metformin and/or basal insulin, once-weekly tirzepatide lowered HbA1c more than placebo at 30 weeks (-2.23% vs +0.05%; estimated treatment difference -2.28 percentage points, 95% CI -2.87 to -1.69; P<0.0001). BMI also fell, but the blinded period was short and the comparator was placebo rather than an active incretin therapy.
PICO Summary
| Element | Detail |
|---|---|
| Population | 99 participants aged 10 to <18 years with youth-onset type 2 diabetes inadequately controlled with metformin and/or basal insulin; phase 3, double-blind, placebo-controlled RCT across 39 sites in eight countries. |
| Intervention | Once-weekly tirzepatide 5 mg (n=32) or 10 mg (n=33), pooled for the primary efficacy analysis, with background metformin and/or basal insulin continued. |
| Comparison | Matching placebo (n=34) with the same background metformin and/or basal insulin. |
| Outcome | At week 30, pooled tirzepatide changed HbA1c by -2.23% versus +0.05% with placebo, for an estimated treatment difference of -2.28 percentage points (95% CI -2.87 to -1.69; P<0.0001). BMI changed by -7.4% with 5 mg and -11.2% with 10 mg versus +0.4% with placebo; two of 32 participants in the 5 mg group discontinued because of adverse events. |
Tirzepatide in Youth T2D (SURPASS-PEDS)
Phase 3 RCT - youth T2D - 30 weeks
Weekly tirzepatide substantially improved HbA1c and reduced BMI versus placebo over 30 weeks in youth-onset type 2 diabetes, but longer-term pediatric comparative data remain limited.
Expert Commentary
SURPASS-PEDS is clinically important because youth-onset type 2 diabetes progresses quickly and treatment options remain limited. The HbA1c effect is large, the randomized double-blind design is appropriate, and the accompanying BMI reduction strengthens the biological signal rather than asking us to rely on glucose alone. Can I use this with my patients? As of July 20, 2026, in the United States, yes for selected patients aged 10 years and older with type 2 diabetes, because the current Mounjaro label includes this pediatric indication. Even so, I would keep this in specialist care with structured follow-up. The 52-week extension signal is encouraging, but the published abstract does not provide enough detail to tell us how durable control, tolerability, and adherence will be in routine practice. Only 99 participants were randomized, placebo was the comparator rather than an active GLP-1 receptor agonist, and the blinded period lasted 30 weeks, which is too short to settle pancreatitis risk, gallbladder events, and nutritional issues in adolescent care. Eli Lilly funded the trial, which is expected in a registration program but still means independent post-marketing data matter. The next step should be longer pediatric safety follow-up and head-to-head trials against semaglutide, insulin intensification, and metabolic surgery pathways.
References
Hannon TS, Chao LC, Barrientos-Perez M, et al. Efficacy and safety of tirzepatide in children and adolescents with type 2 diabetes (SURPASS-PEDS): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2025;406(10511):1484-1496. doi:10.1016/S0140-6736(25)01774-X. PMID: 40975112.